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FDA ANDA · ANDA062999

E-BASE

Sponsor: BARR

APPLICATION
ANDA062999
TYPE
ANDA
ORIGINAL APPROVAL
1988-11-25
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

E-BASEDiscontinued
ERYTHROMYCIN 500MG · TABLET, DELAYED RELEASE · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 8AP
1994-12-23Manufacturing (CMC) · Supplement 7AP
1994-10-11Manufacturing (CMC) · Supplement 6AP
1993-04-27Labeling · Supplement 5AP
1992-08-21Labeling · Supplement 4AP
1992-04-03Manufacturing (CMC) · Supplement 3AP
1992-04-03Manufacturing (CMC) · Supplement 1AP
1988-11-25OriginalAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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